The opportunity
This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics, IVD, and Clinical Research expertise to drive the strategy, design, analysis,…
What you'll do
Strategic Study Design and Analysis: Independently lead the design, analysis, and interpretation of clinical validation studies to support in vitro diagnostic approvals (e.g., CDx, 510(k), PMA, etc.)
Regulatory Compliance: Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as FDA. Drive statistical interactions with regulatory authorities.
Documentation and Reporting: Prepare comprehensive statistical analysis protocols (SAPs), reports, and presentations for cross-functional and external collaborators and stakeholders.
Cross-Functional Leadership: Serve as the statistical lead on high-priority project teams. Partner with Clinical Science, Data Management, and Product teams to integrate statistical expertise into project planning and execution. Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams
Clinical Research and Beyond: Drive design and execution of high-impact research clinical trials, studies, and publications that push the development of our world-class product portfolio
Stay current with advancements in Biostatistics and clinical validation: methodology, implementing innovative approaches to support diagnostic product development and regulatory submissions
What they're looking for
- Mentor and provide technical supervision to junior team members
- Education : Ph.D. or Master's degree in Biostatistics, Statistics, or a related field
- Experience :
- At least 8 years of relevant industry experience, preferably within molecular: diagnostics, biotechnology, or related fields.
